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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test Kit

Manufactured by Koch Biotechnology (Beijing) Co. Ltd., China - www.kochbiotech.net 

Device identification number
2038
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Strip
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is an in-vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal- (Nasopharynx) or oropharyngeal- (throat) swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. The KOCH COVID-19 Antigen Rapid Test Kit is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a blood donor screening test for SARS-CoV-2. The KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is based on colloidal gold immunochromatography to detect nucleocapsid (N) of the SARS-CoV-2 virus in respiratory secretions. When the specimen is added into the solution buffer inside the virus preservation tube and the test stripe has been added, the specimen is absorbed by the test stripe by capillary action, mixes with the gold-labelled antibody and flows across the pre-coated membrane. The antigen in the sample is captured by the gold-labelled antibody N1a and then bound to the antibody N1 immobilized in the test region (T) of the membrane. This creates a coloured line and indicates a positive test result. If there is no COVID-19 antigen in the specimen or the concentration is lower than the detection limit of the test, there is not a visible coloured line in the Test Region (T) of the device. This indicates a negative result. To serve as a procedure control, a coloured line will appear at the Control Region (C), if the test has been performed properly
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
115
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
0.7 %
Precision
Evaluated
Accuracy
99 % ((95%CI*: 98,30-99,70%))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.5 % ((95%CI*: 97,20-99,80%))
Clinical Specificity
99.3 % ((95%CI*: 98,50-100%))
Type of antigen
Nucleoprotein

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements